DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on December 9, 2024 were received and fully considered. Claims 1, 3-5, 11, and 13-15 were amended. Claims 9-10 an 19-20 were cancelled. Claims 21 and 22 were added Please see below for more detail.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “using the glucose monitoring device to, for each glucose level measurement in the data set of glucose level measurements, determine a sub-range of a plurality of glucose level sub-ranges into which the glucose level measurement falls;”
“using the processor of the glucose monitoring device to, for each of the plurality of glucose level sub-ranges, calculate a value indicative of an amount of time that glucose levels of the patient were within the sub-range using the glucose level sub-ranges into which the glucose level measurements in the data set of glucose level measurements were determined to fall;” which amounts to an abstract idea (mental process and mathematical concepts).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“using a glucose monitoring sensor of a glucose monitoring system to measure glucose levels of a patient during a period of time, wherein using the glucose monitoring sensor of the glucose monitoring system to measure the glucose levels of the patient comprises using a fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient, using the fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence;”
“using a glucose monitoring device of the glucose monitoring system to communicate over a wireless communication link;”
“using a glucose monitoring device of the glucose monitoring system to receive from the glucose monitoring sensor a data set of glucose level measurements of the patient;”
“using a display of the glucose monitoring device to display a first graphical element comprising the plurality of glucose level sub-ranges and the calculated values indicative of the amounts of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time.”
“wherein an expected range for the glucose level measurements is divided into the plurality of glucose level sub-ranges such that the plurality of glucose level sub-ranges do not overlap and together form the expected range for the glucose level measurements.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, glucose monitoring sensors are general fields of use and displays are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of calculating values indicative of an amount of time that glucose of a patient was within each sub-range of glucose values from a plurality of sub-ranges of glucose values and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 2-10 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 11, the claim(s) recites “for each glucose level measurement in the data set of glucose level measurements, determine a sub-range of a plurality of glucose level sub-ranges into which the glucose level measurement falls;”
“for each of the plurality of glucose level sub-ranges, calculate a value indicative of an amount of time that glucose levels of the patient were within the sub-range using the glucose level sub-ranges into which the glucose level measurements in the data set of glucose level measurements were determined to fall;” which amounts to an abstract idea (mental process and mathematical concepts).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a glucose monitoring sensor configured to measure glucose levels of a patient during a period of time, wherein using the glucose monitoring sensor of the glucose monitoring system to measure the glucose levels of the patient comprises using a fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient, using the fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence,”
“communicate over a wireless communication link”
“a glucose monitoring device comprising a processor and a display,
“wherein the glucose monitoring device is configured to:
receive from the glucose monitoring sensor a data set of glucose level measurements of the patient;”
“use the display of the glucose monitoring device to display a first graphical element comprising the plurality of glucose level sub-ranges and the calculated values indicative of the amounts of time the glucose levels of the patient werewithin each of the plurality of glucose level sub-ranges during the period of time.”
“wherein an expected range for the glucose level measurements is divided into the plurality of glucose level sub-ranges such that the plurality of glucose level sub-ranges do not overlap and together form the expected range for the glucose level measurements.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, glucose monitoring sensors are general fields of use and displays are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of calculating values indicative of an amount of time that glucose of a patient was within each sub-range of glucose values from a plurality of sub-ranges of glucose values and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 12-20 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 6, 11, 13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray et al (US 2011/0245634) (“Ray”) in view of Rebec et al (US 2008/0051645) (“Rebec”) and further in view of Salas-Boni et al (US 2016/0029966) (“Salas-Boni”).
Regarding Claim 1, while Ray teaches a glucose monitoring method (Abstract, Figs. 4D, 16, 20-21, [0056]-[0057], [0070], [0077], [0079]-[0081], [0085]-[0088], [0111]-[0115], [0125]-[0127]) comprising:
using a glucose monitoring sensor of a glucose monitoring system to measure glucose levels of a patient during a period of time ([0056]-[0057], [0066]-[0069] glucose meter measures glucose levels of a patient, continuous data measurement for a period of time);
using the glucose monitoring sensor to communicate over a wireless communication link ([0056] analyte measurement and management units communicates wirelessly to a glucose-insulin data management unit);
using a glucose monitoring device of the glucose monitoring system to receive from the glucose monitoring sensor a data set of glucose level measurements of the patient ([0066]-[0069]);
using a processor of the glucose monitoring device to, for each glucose level measurement in the data set of glucose level measurements, determine a sub-range of a plurality of glucose level sub-ranges into which the glucose level measurement falls ([0079]-[0081], [0085]-[0088] identify sub-ranges of a plurality of glucose level measurements and determine where glucose level measurements fall within identified sub-ranges, with a first sub-range of normal glucose values and a second sub-range of excursion values, Fig. 16, [0111]-[0115] where the sub-ranges can be expanded to characterize specific conditions in the patient and/or varying levels of risk for a patient, Fig. 21, [0125]-[0127] exemplary specific sub-ranges for cardiac complications and renal/eye complication, [0067], [0149] microprocessor provides the analysis disclosed herein);
using the processor of glucose monitoring device to, for each of the plurality of glucose level sub-ranges, calculate a value indicative of an amount of time that glucose levels of the patient were within the sub-range using the glucose level sub-ranges into which the glucose level measurements in the data set of glucose level measurements were determined to fall ([0070] calculated excursion areas, the areas under the curve, are calculations of sub-ranges of glucose level measurements and excursion areas are values indicative of an amount of time that glucose of the patient was within the sub-range, Figs. 16 and 21, [0111]-[0115], [0125]-[0127]);
using a display of the glucose monitoring device to display a first graphical element comprising the plurality of glucose level sub-ranges and the calculated values indicative of the amounts of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time ([0077] display of glucose monitoring can be of the probability density curve determined from the plurality of measurements / the plurality of glucose level sub-ranges, [0109] excursion areas are displayed and are calculated values indicative of amount of time the glucose levels were within each of the sub-ranges),
Ray fails to teach wherein using the glucose monitoring sensor of the glucose monitoring system to measure the glucose levels of the patient comprises using a fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient, using the fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence.
However Rebec teaches a glucose monitor based on fluorescence (Abstract, [0028], [0067], [0084]) using a fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient ([0084]), using the fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence ([0075]-[0076] after excitation by light, the parameters will include wavelength distribution to identify the change in wavelengths caused by analyte presence).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the glucose meter of Ray as a fluorescence-based glucose measuring fluorometer as taught by Rebec to standardize the designs of the system, and ensure greater consistency across glucose measuring trials.
Yet their combined efforts fail to teach wherein an expected range for the glucose level measurements is divided into the plurality of glucose level sub-ranges such that the plurality of glucose level sub-ranges do not overlap and together form the expected range for the glucose level measurements.
However Salas-Boni teaches a method for analyzing analyte data (Abstract) comprising
determine a sub-range of a plurality of glucose level sub-ranges into which the glucose level measurement falls in a data set of glucose level measurements (Fig. 7B, [0070]-[0071]),
wherein an expected range for the glucose level measurements is divided into the plurality of glucose level sub-ranges such that the plurality of glucose level sub-ranges do not overlap and together form the expected range for the glucose level measurements (Fig. 7B, [0070]-[0071] plurality of glucose level sub-ranges are divided by normal levels, low levels, and high levels, and do not overlap);
calculate a value indicative of an amount of time that glucose levels of the patient were within the sub-range using the glucose level sub-ranges into which the glucose level measurements in the data set of glucose level measurements were determined to fall ([0070]-[0071] area under the curve calculations).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set distinct sub-ranges for the values indicative of amount of time that glucose levels were within a sub-range of Ray as taught by Salas-Boni as a simpler form of communicating glucose range information. For example, with the teachings of Ray, a sub-range of values above normal and values that are critically high would overlap, and would require a subtraction step to distinguish when the subject is above normal, but not yet critically high. The distinct categories of Salas-Boni obviate this potential extra calculation step.
Regarding Claim 3, Ray, Rebec, and Salas-Boni teach the method of claim 1, wherein the first graphical element is a curve graph indicating the amount of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time (See Claim 1 Rejection).
Regarding Claim 6, Ray, Rebec, and Salas-Boni teach the method of claim 1, wherein the value is the number of glucose level measurements within the sub-range (See Claim 1 Rejection, [0066] distribution of number of glucose level measurements used to generate curves, Fig. 3D, 4D).
Regarding Claim 11, Ray teaches a glucose monitoring system (Abstract, Figs. 4D, 16, 20-21, [0056]-[0057], [0070], [0077], [0079]-[0081], [0085]-[0088], [0111]-[0115], [0125]-[0127]) comprising:
a glucose monitoring sensor configured to measure glucose levels of a patient during a period of time ([0056]-[0057], [0066]-[0069] glucose meter measures glucose levels of a patient, continuous data measurement for a period of time) and, in measuring the glucose levels of the patient, the glucose monitoring sensor is configured to:
communicate over a wireless communication link ([0056] analyte measurement and management unit communicate wirelessly to a glucose-insulin data management unit);
a glucose monitoring device comprising a processor and a display ([0066]-[0069], [0149] microprocessor provides the analysis disclosed herein), wherein the glucose monitoring device is configured to:
receive from the glucose monitoring sensor a data set of glucose level measurements of the patient ([0056]-[0057], [0066]-[0069] glucose meter measures glucose levels of a patient, continuous data measurement for a period of time);
for each glucose level measurement in the data set of glucose level measurements, determine a sub-range of a plurality of glucose level sub-ranges into which the glucose level measurement falls ([0079]-[0081], [0085]-[0088] identify sub-ranges of a plurality of glucose level measurements and determine where glucose level measurements fall within identified sub-ranges, with a first sub-range of normal glucose values and a second sub-range of excursion values, Fig. 16, [0111]-[0115] where the sub-ranges can be expanded to characterize specific conditions in the patient and/or varying levels of risk for a patient, Fig. 21, [0125]-[0127] exemplary specific sub-ranges for cardiac complications and renal/eye complication);
for each of the plurality of glucose level sub-ranges, calculate a value indicative of an amount of time that glucose of the patient were within the sub-range using the glucose level sub-ranges into which the glucose level measurements in the data set of glucose level measurements were determined to fall ([0070] calculated excursion areas, the areas under the curve, are calculations of sub-ranges of glucose level measurements and excursion areas are values indicative of an amount of time that glucose of the patient was within the sub-range, Figs. 16 and 21, [0111]-[0115], [0125]-[0127]); and
use the display of the glucose monitoring device to display a first graphical element comprising the plurality of glucose level sub-ranges and the calculated values indicative of the amounts of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time ([0077] display of glucose monitoring can be of the probability density curve determined from the plurality of measurements / the plurality of glucose level sub-ranges, [0109] excursion areas are displayed and are calculated values indicative of amount of time the glucose levels were within each of the sub-ranges).
Ray fails to teach wherein using the glucose monitoring sensor of the glucose monitoring system to measure the glucose levels of the patient comprises using a fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient, using the fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence.
However Rebec teaches a glucose monitor based on fluorescence (Abstract, [0028], [0067], [0084]) using a fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient ([0084]), using the fluorometer of the glucose monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence ([0075]-[0076] after excitation by light, the parameters will include wavelength distribution to identify the change in wavelengths caused by analyte presence).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the glucose meter of Ray as a fluorescence-based glucose measuring fluorometer as taught by Rebec to standardize the designs of the system, and ensure greater consistency across glucose measuring trials.
Yet their combined efforts fail to teach wherein an expected range for the glucose level measurements is divided into the plurality of glucose level sub-ranges such that the plurality of glucose level sub-ranges do not overlap and together form the expected range for the glucose level measurements.
However Salas-Boni teaches a method for analyzing analyte data (Abstract) comprising
determine a sub-range of a plurality of glucose level sub-ranges into which the glucose level measurement falls in a data set of glucose level measurements (Fig. 7B, [0070]-[0071]),
wherein an expected range for the glucose level measurements is divided into the plurality of glucose level sub-ranges such that the plurality of glucose level sub-ranges do not overlap and together form the expected range for the glucose level measurements (Fig. 7B, [0070]-[0071] plurality of glucose level sub-ranges are divided by normal levels, low levels, and high levels, and do not overlap);
calculate a value indicative of an amount of time that glucose levels of the patient were within the sub-range using the glucose level sub-ranges into which the glucose level measurements in the data set of glucose level measurements were determined to fall ([0070]-[0071] area under the curve calculations).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set distinct sub-ranges for the values indicative of amount of time that glucose levels were within a sub-range of Ray as taught by Salas-Boni as a simpler form of communicating glucose range information. For example, with the teachings of Ray, a sub-range of values above normal and values that are critically high would overlap, and would require a subtraction step to distinguish when the subject is above normal, but not yet critically high. The distinct categories of Salas-Boni obviate this potential extra calculation step.
Regarding Claim 13, Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 11, wherein the first graphical element is a curve graph indicating the amount of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time (See Claim 11 Rejection).
Regarding Claim 16, Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 11, wherein the value is the number of glucose level measurements within the sub-range (See Claim 11 Rejection, [0066] distribution of number of glucose level measurements used to generate curves, Fig. 3D, 4D).
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of Rebec and further in view of Salas-Boni and further in view of Wesley et al (US 2014/0206970) (“Wesley”).
Regarding Claim 2, while Ray, Rebec, and Salas-Boni teach the method of claim 1, further comprising:
using the glucose monitoring device to calculate an average glucose level based on the received data set of glucose level measurements (Figs. 11-12, [0098]-[0099], [0102] average glucose level found);
using the glucose monitoring device to calculate an estimated HbA1c based on the received data set of glucose level measurements ([0070], [0089]);
using the display of the glucose monitoring device to display a second graphical element comprising one or more of the average glucose level, the estimated HbA1c range, the standard deviation of glucose levels, and the period of time ([0082] period of time of overall glucose measurements is displayed, [0094] estimated characteristic values can be displayed, [0089] which includes HbA1c predicted value), Ray fails to teach
using the glucose monitoring device to calculate an estimated HbA1c range based on the received data set of glucose level measurements; and
using the glucose monitoring device to calculate a standard deviation of glucose levels based on the received data set of glucose level measurements.
However Wesley teaches a glucose management system (Abstract) comprising an identification of glucose statistics (Fig. 7, [0050]) including
using the glucose monitoring device to calculate an average glucose level based on the received data set of glucose level measurements ([0053]-[0054]);
using the glucose monitoring device to calculate an estimated HbA1c based on the received data set of glucose level measurements ([0055]);
using the glucose monitoring device to calculate a standard deviation of glucose levels based on the received data set of glucose level measurements ([0056]-[0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further identify a standard deviation as taught by Wesley for the glucose parameters of Ray as this measure will reflect a level of certainty in patient trajectory. Furthermore, if one has a measure of standard deviation of glucose levels and a measure of HbA1c, then a practitioner has a broad measure of a range of HbA1c values based on the deviations seen in the glucose measurement dataset. Calculating an HbA1c estimate range by performing the formula of [0055] on a deviation range off of the average value would be a trivial extra step to provide an exact metric for data that has already been collected.
Regarding Claim 12, while Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 11, wherein the glucose monitoring device is further configured to:
calculate an average glucose level based on the received data set of glucose level measurements (Figs. 11-12, [0098]-[0099], [0102] average glucose level found);
calculate an estimated HbA1c range based on the received data set of glucose level measurements ([0070], [0089]);
use the display of the glucose monitoring device to display a second graphical element comprising one or more of the average glucose level, the estimated HbA1c range, the standard deviation of glucose levels, and the period of time ([0082] period of time of overall glucose measurements is displayed, [0094] estimated characteristic values can be displayed, [0089] which includes HbA1c predicted value),
Ray fails to teach calculate an estimated HbA1c range based on the received data set of glucose level measurements; and
calculating a standard deviation of glucose levels based on the received data set of glucose level measurements.
However Wesley teaches a glucose management system (Abstract) comprising an identification of glucose statistics (Fig. 7, [0050]) including
using the glucose monitoring device to calculate an average glucose level based on the received data set of glucose level measurements ([0053]-[0054]);
using the glucose monitoring device to calculate an estimated HbA1c based on the received data set of glucose level measurements ([0055]);
using the glucose monitoring device to calculate a standard deviation of glucose levels based on the received data set of glucose level measurements ([0056]-[0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further identify a standard deviation as taught by Wesley for the glucose parameters of Ray as this measure will reflect a level of certainty in patient trajectory. Furthermore, if one has a measure of standard deviation of glucose levels and a measure of HbA1c, then a practitioner has a broad measure of a range of HbA1c values based on the deviations seen in the glucose measurement dataset. Calculating an HbA1c estimate range by performing the formula of [0055] on a deviation range off of the average value would be a trivial extra step to provide an exact metric for data that has already been collected.
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of Rebec and further in view of Salas-Boni and further in view of Breton et al (US 2011/0264378) (“Breton”).
Regarding Claim 7, while Ray, Rebec, and Salas-Boni teach the method of claim 1, their combined efforts fail to teach wherein the value is a calculation of a cumulative amount of time within the sub-range.
However Breton teaches a system for tracking blood glucose variability (Abstract) and teaches that target ranges of glucose can be characterized for a time period by a percentage of the period of time that the glucose level measurement was within the sub-range and a calculation of a cumulative amount of time within the sub-range ([0181]-[0183], Tables 4 and 5, aggregated time spent in three different glucose ranges, below a target range, within a target range, and above a target range).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the value of Ray as a cumulative amount of time within the sub-range as Breton teaches that this is an alternative form of showing distribution of blood glucose over a time period. Thus, it is a simple substitution of one form of representing blood glucose distribution over a time period (Ray: number of occurrences) for another (Breton: combined duration of occurrences) to obtain predictable results of identifying the characteristic glucose levels of a patient.
Regarding Claim 17, while Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 11, their combined efforts fail to teach wherein the value is a calculation of a cumulative amount of time within the sub-range.
However Breton teaches a system for tracking blood glucose variability (Abstract) and teaches that target ranges of glucose can be characterized for a time period by a percentage of the period of time that the glucose level measurement was within the sub-range and a calculation of a cumulative amount of time within the sub-range ([0181]-[0183], Tables 4 and 5, aggregated time spent in three different glucose ranges, below a target range, within a target range, and above a target range).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the value of Ray as a cumulative amount of time within the sub-range as Breton teaches that this is an alternative form of showing distribution of blood glucose over a time period. Thus, it is a simple substitution of one form of representing blood glucose distribution over a time period (Ray: number of occurrences) for another (Breton: combined duration of occurrences) to obtain predictable results of identifying the characteristic glucose levels of a patient.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of Rebec and further in view of Salas-Boni and further in view of Fine et al (US 2004/0225205) (“Fine”).
Regarding Claim 8, while Ray, Rebec, and Salas-Boni teach the method of claim 1, their combined efforts fail to teach wherein the value is a percentage of the period of time that the glucose level measurement was within the sub-range.
However Fine teaches a glucose level control system (Abstract) comprising organizing the distribution of the blood glucose values as percentage of occurrence of specific blood glucose levels ([0048]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the value of Ray as percentage of period of time that the glucose level was within a sub-range as Fine teaches that this is an alternative form of showing distribution of blood glucose over a time period. Thus, it is a simple substitution of one form of representing blood glucose distribution over a time period for another to obtain predictable results of identifying the characteristic glucose levels of a patient.
Regarding Claim 18, while Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 11, their combined efforts fail to teach wherein the value is a percentage of the period of time that the glucose level measurement was within the sub-range.
However Fine teaches a glucose level control system (Abstract) comprising organizing the distribution of the blood glucose values as percentage of occurrence of specific blood glucose levels ([0048]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the value of Ray as percentage of period of time that the glucose level was within a sub-range as Fine teaches that this is an alternative form of showing distribution of blood glucose over a time period. Thus, it is a simple substitution of one form of representing blood glucose distribution over a time period for another to obtain predictable results of identifying the characteristic glucose levels of a patient.
Claim(s) 4-5, 14-15, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of Rebec and further in view of Salas-Boni and further in view of Cabrera Jr et al (US 2018/0042559) (“Cabrera”).
Regarding Claim 4, while Ray, Rebec, and Salas-Boni teach the method of claim 3, further comprising:
using the glucose monitoring device to calculate a first area under the curve graph according to a first sub-range of the plurality of glucose level sub-ranges of the first area under the curve graph (See Claim 3 Rejection, Ray’s excursion areas and Salas-Boni’s area under the curves in Fig. 7B); and
using the display of the glucose monitoring device to display the first area (See Claim 3 Rejection, Ray’s display of excursion areas and Salas-Boni’s display of areas under curve graphs);
where a second assessment result of the glycemic control may be transmitted to a user ([0109]),
Yet their combined efforts fail to teach using the display of the glucose monitoring device to display the first area as a first color;
using the display of the glucose monitoring device to display a second graphical element comprising the calculated first area.
However Cabrera teaches a glucose management system (Abstract) comprising an identification of glucose within calculated area under a curve with respect to time, where particular sub-ranges of glucose values are represented with different colors (Fig. 30, [0313]-[0317] different areas ae shaded differently to visually distinguish, with visual indicators including color) and also teaches a graphical display including both numerical magnitude values and a curve graph (Fig. 29, [0310] magnitude glass 202 and glucose trend graph 2904).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to display the area under the curve specific to particular glucose sub-ranges as taught by Ray in different colors as taught by Cabrera to visually create an immediately identifiable distinction in data, improving legibility of the display data. Furthermore, it would obvious to one of ordinary skill in the art to transmit the assessment results by an identifiable metric as taught by Ray by specifically providing a magnitude value as taught by Cabrera as a simple substitution of Ray’s displayed metric of a preset phrases representing area (Ray: [0109]) for Cabrera’s displayed metric of a numerical value to obtain predictable results of a providing a distinguishing metric for a practitioner to readily recognize patient progress.
Regarding Claim 5, Ray, Rebec, Salas-Boni, and Cabrera teach the method of claim 4, further comprising:
using the glucose monitoring device to calculate a second area under the curve graph according a second sub-range of the plurality of glucose sub-ranges;
using the glucose monitoring device to calculate an area of the second area as a second color; and
using the display of the glucose monitoring device to display the second graphical element further comprising the calculated area of the second area under the curve graph (See Claim 4 Rejection, Ray and Salas-Boni describes multiple areas specific to risk and condition, so the steps of Claim 4 would be reapplied for the second excursion area, with different colors for different sub-ranges).
Regarding Claim 21, while Ray, Rebec, and Salas-Boni teach the method of claim 1, wherein the first graphical element is a curve graph indicating the amounts of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time, and the glucose monitoring device is further configured to, for each sub-range of the plurality of glucose level sub-ranges:
calculate an area under the curve graph corresponding to the sub-range (See Claim 1 Rejection), their combined efforts fail to teach
use the display of the glucose monitoring device to display the area under the
curve graph corresponding to the sub-range as a color that is different than a displayed
color of an area under the curve graph corresponding to another sub-range of the plurality
of glucose level sub-ranges; and
using the display of the glucose monitoring device to display a second graphical
element comprising the calculated area under the curve graph corresponding to the sub-range.
However Cabrera teaches a glucose management system (Abstract) comprising an identification of glucose within calculated area under a curve with respect to time, where particular sub-ranges of glucose values are represented with different colors (Fig. 30, [0313]-[0317] different areas ae shaded differently to visually distinguish, with visual indicators including color) and also teaches a graphical display including both numerical magnitude values and a curve graph (Fig. 29, [0310] magnitude glass 202 and glucose trend graph 2904).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to display the area under the curve specific to particular glucose sub-ranges as taught by Ray in different colors as taught by Cabrera to visually create an immediately identifiable distinction in data, improving legibility of the display data. Furthermore, it would obvious to one of ordinary skill in the art to transmit the assessment results by an identifiable metric as taught by Ray by specifically providing a magnitude value as taught by Cabrera as a simple substitution of Ray’s displayed metric of a preset phrases representing area (Ray: [0109]) for Cabrera’s displayed metric of a numerical value to obtain predictable results of a providing a distinguishing metric for a practitioner to readily recognize patient progress.
Regarding Claim 14, while Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 13, wherein the glucose monitoring device is further configured to:
calculate a first area under the curve graph according to a first sub-range of the plurality of glucose level sub-ranges (See Claim 13 Rejection, Ray’s excursion areas and Salas-Boni’s area under the curves in Fig. 7B); and
use the display of the glucose monitoring device to display the first area (See Claim 3 Rejection, Ray’s excursion areas and Salas-Boni’s area under the curves in Fig. 7B);
Yet their combined efforts fail to teach using the display of the glucose monitoring device to display the first area as a first color;
using the display of the glucose monitoring device to display a second graphical element comprising the calculated first area.
However Cabrera teaches a glucose management system (Abstract) comprising an identification of glucose within calculated area under a curve with respect to time, where particular sub-ranges of glucose values are represented with different colors (Fig. 30, [0313]-[0317] different areas ae shaded differently to visually distinguish, with visual indicators including color) and also teaches a graphical display including both numerical magnitude values and a curve graph (Fig. 29, [0310] magnitude glass 202 and glucose trend graph 2904).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to display the area under the curve specific to particular glucose sub-ranges as taught by Ray in different colors as taught by Cabrera to visually create an immediately identifiable distinction in data, improving legibility of the display data. Furthermore, it would obvious to one of ordinary skill in the art to transmit the assessment results by an identifiable metric as taught by Ray by specifically providing a magnitude value as taught by Cabrera as a simple substitution of Ray’s displayed metric of a preset phrases representing area (Ray: [0109]) for Cabrera’s displayed metric of a numerical value to obtain predictable results of a providing a distinguishing metric for a practitioner to readily recognize patient progress.
Regarding Claim 15, Ray, Rebec, Salas-Boni, and Cabrera teach the glucose monitoring system of claim 14, wherein the glucose monitoring device is further configured to:
calculate an area of the second area under the curve graph according to a second sub-range of the plurality of glucose sub-ranges;
use the display of the glucose monitoring device to display the second area as a second color; and
wherein the second graphical element further comprises the calculated area of the second area under the curve graph (See Claim 14 Rejection, Ray describes multiple excursion areas specific to risk and condition, so the steps of Claim 14 would be reapplied for the second excursion area, with different colors for different sub-ranges).
Regarding Claim 22, while Ray, Rebec, and Salas-Boni teach the glucose monitoring system of claim 11, wherein the first graphical element is a curve graph indicating the amounts of time the glucose levels of the patient were within each of the plurality of glucose level sub-ranges during the period of time, and the glucose monitoring device is further configured to, for each sub-range of the plurality of glucose level sub-ranges:
calculate an area under the curve graph corresponding to the sub-range (See Claim 14 Rejection), their combined efforts fail to teach use the display of the glucose monitoring device to display the area under the curve graph corresponding to the sub-range as a color that is different than a displayed color of an area under the curve graph corresponding to another sub-range of the plurality of glucose level sub-ranges; and
using the display of the glucose monitoring device to display a second graphical element comprising the calculated area under the curve graph corresponding to the sub-range.
However Cabrera teaches a glucose management system (Abstract) comprising an identification of glucose within calculated area under a curve with respect to time, where particular sub-ranges of glucose values are represented with different colors (Fig. 30, [0313]-[0317] different areas ae shaded differently to visually distinguish, with visual indicators including color) and also teaches a graphical display including both numerical magnitude values and a curve graph (Fig. 29, [0310] magnitude glass 202 and glucose trend graph 2904).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to display the area under the curve specific to particular glucose sub-ranges as taught by Ray in different colors as taught by Cabrera to visually create an immediately identifiable distinction in data, improving legibility of the display data. Furthermore, it would obvious to one of ordinary skill in the art to transmit the assessment results by an identifiable metric as taught by Ray by specifically providing a magnitude value as taught by Cabrera as a simple substitution of Ray’s displayed metric of a preset phrases representing area (Ray: [0109]) for Cabrera’s displayed metric of a numerical value to obtain predictable results of a providing a distinguishing metric for a practitioner to readily recognize patient progress.
Response to Arguments
Applicant’s amendments and arguments filed 4/07/2026 with respect to the 35 USC 101 rejections have been fully considered, but are not persuasive.
Applicant argues in pages 11-13 that the claims recite a particular machine i.e. by a particular system that uses a fluorometer and a processor and display. Examiner respectfully disagrees. Examiner maintains that the claimed hardware is general of use limitations. While Applicant states that the fluorometer is not a generic sensor because it is a specific type of sensor, Ockenfuss (US 2014/0170765 noted in Applicant IDS dated 4/08/2024) states that spectrofluorometers are widely used and miniature fluorometers are used in glucose monitoring settings.
Applicant argues in pages 13-14 that the claims require a transformation step by the fluorometer-based glucose sensors and furthermore, the claims are not limited to data gathering. Examiner respectfully disagrees. A transformation in fluorescence due to excitation in light is a step necessary to the gathering of glucose data. Specifically, this glucose data must be gathered to provide the basis for the mental steps, i.e. the input being analyzed mentally. As the transformation is considered extra-solution data gathering, the limitations do not provide significantly more. See MPEP 2106.05(c).
Applicant’s amendments and arguments filed 4/07/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ray, Rebec, and Salas-Boni.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights